Enrollment commences in belinostat-Tarceva combination trial for NSCLC

Spectrum Pharmaceuticals (NasdaqGM: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, and Topotarget A/S announced today that the first patient has been dosed in an Investigator Initiated Trial of belinostat in combination with Tarceva^® for patients with Non-Small Cell Lung Cancer (NSCLC). The primary objective of the study is to evaluate the safety of belinostat in combination with Tarceva and to generate efficacy data in terms of progression-free survival, response rate and overall survival in patients with NSCLC.

"We are pleased that this trial investigating belinostat's safety and efficacy in combination with Tarceva has enrolled its first patient," said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. "Belinostat is an HDAC inhibitor with the potential safety advantage that allows for full-dose combination with other chemotherapeutic regimens. Preclinical data has demonstrated synergy between belinostat and Tarceva. We look forward to the results of this Phase I/II trial with Tarceva, which is an FDA-approved oral drug for advanced NSCLC."

The study is an open-label, prospective Phase I/II trial of belinostat in combination with Tarceva in patients with previously treated NSCLC. Belinostat is given orally on days 1-14, while Tarceva is administered orally continuously. The Phase I/II trial is expected to enroll a total of 35 patients.